1. Field of the Invention
The present invention relates to a spironolactone composition for combatting acne.
2. Description of the Prior Art
Acne is a chronic phlogistic disease which is potentially present in all young people. It is clinically characterized by comedones, papules, nodules and cysts. No differences between sexes are noted and all human races are subjected to it.
Acne is considered as a physiological condition in adolescents. On the other hand it may be induced or aggravated by drugs, chemical agents such as oils, chlorinated hydrocarbons, tar and the like, and by conditions preventing perspiration such as too heavy clothes in tropical climates. Drugs favoring acne in predisposed subjects are ACTH, corticosteroids, testosterone, gonadotropins, oral contraceptives, trimethadone, iodides and bromides. Sometimes whole families are particularly hit by acne, and this fact suggest a hereditary factor. Dietetic factors were overevaluated in the past.
Lesions caused by acne are generally subdivided into phlogistic and non-phlogistic lesions. They are typically spread on the face, although periorbital areas are excluded, on the back, thorax and shoulders. Non-phlogistic lesions include open and closed comedones ("black spots" and "white spots"). An open comedo consists of a small flat or prominent area with a central hole containing keratine and lipids; actually, the comedo is a pilo-sebaceous follicle containing a keratine plug. The plug top is dark being oxidated. A closed comedonic pore is surmonted by epithelium; this is the lesion present as a papule unless the epithelium is removed. Since keratine is enclosed within the comedo, it represents a potential source of phlogistic lesions such as erythematous papules, nodules and cysts.
It has been now discovered that acne can be effectively combatted by percutaneous treatment with a spironolactone containing pharmaceutical composition. Spironolactone is generally used in those diseases in which its effectiveness may be attributed to its activity as an aldosterone antagonist. However, spironolactone generally displays a number of undesirable side effects due to a suggested interference with androgenic action, including decreased testosterone formation and other possible mechanisms, which may induce sexual impotence, decrease in libido, gynecomastia and similar disturbances of hormone balance.
It is therefore one purpose of this invention to provide a spironolactone composition effective in combatting acne, and at the same time being devoid of undesirable side effects, which may have a severe psychological influence on treated subjects, especially those who are in their age of growth and adolescence.
Another purpose of this invention is to provide such a spironolactone composition in the form of a cream, which on topical skin application gives an effective concentration of spironolactone on the site where it is desired it to act on acne with beneficial effects.
A further purpose of this invention is to provide such a spironolactone formulation which is only adsorbed by skin where it is applied, but does not penetrate through the skin in such a way as to be circulated in the body, thus preventing the above mentioned undesired side effects.